PROCESS DEVELOPMENT

Our Approach

Avecia’s Process Development team helps to advance your oligonucleotide from the lab through the clinic, and into validation and commercial manufacture by implementing a safe, robust, and cost-effective process.

We continue to advance our development approach to include all relevant guidances and standards, currently including ICH Q8, 9, 10, and 11, and the 2011 FDA guidance for Process Validation. Avecia communicates regularly with industry experts to ensure that our approach is aligned to these updated guidelines.

Avecia process development is conducted with a Quality by Design (QbD) approach and advanced development activities often rely heavily on Design of Experiments (DoE) as a structured approach to experimentation. Our extensive history and knowledge in oligo development has been formalized into our: OliGO: Faster, Smarter, BetterSM approach to process development.

OliGOSM is not a fixed set of parameters to be used for all sequences; our development program is based on the principle that all oligos are unique, and have different challenges associated with their scale up and manufacture. What OliGOSM provides is a baseline process, determined by the specific nature of your oligo sequence, and the cumulative expertise of Avecia’s development and manufacturing teams.

This process can be used ‘out of the box’ to produce a small batch of oligo, or as a starting point for further optimization, depending on the needs of your program. Whether you need an entire process designed or optimized, just one or two parameters modified, or anything in between, the OliGOSM approach can be used to streamline your development activities.

Process parameter screening and robustness testing using Design of Experiments

Pegylations and duplexations

PS, PO, and mixed backbone sequences

Sequences from <10 to >50 bases

Process Performance Qualification activities and support

In addition, our oligonucleotide research has resulted in a list of technologies that we have available for licensing. Click here for the complete list, and contact us at OligoInfo@avecia.com for more information.
For more information on our OliGO: Faster, Smarter, BetterSM approach to process development, contact us at OligoInfo@avecia.com